Schizophrenia
Conditions
Interventions
SEP-363856
(75 mg/day or 100 mg/day)
Sponsors
Sanada Nobuhito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Japanese male or female participants 18 years of age or older at the time of informed consent -Diagnosed with schizophrenia according to the DSM-5 -Judged by the investigator to be clinically stable for at least 8 weeks prior to screening -PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline -No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability)
Exclusion criteria
Exclusion criteria: -History of psychiatric hospitalization within 8 weeks prior to screening -Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks [28 consecutive days] in accordance with the package insert, psychiatric symptoms did not improve) -History of treatment with clozapine -Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment-emergent adverse events(TEAEs) | — |
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed